Continuing medical education and pharmaceutical industry involvement: An evaluation of policies adopted by Canadian professional medical associations

1 Introduction

Professional medical associations (PMAs) provide members with professional educational opportunities including accredited continuing medical education (CME) or continuing professional development (CPD); hereinafter, collectively referred to as CME. However, there is an ongoing debate about whether the CME that these organizations offer may be undermined because of a perception of bias due to either CME funding that they receive from and/or financial ties that organizations have with pharmaceutical and medical device companies, hereafter collectively referred to as the pharmaceutical industry. While some investigators are concerned about this bias [1–4], a systematic review commissioned by the Accreditation Council for Continuing Medical Education found no evidence of bias [5].

It is important for physicians to participate in CME to not only maintain their credentials, but also to keep informed of new pharmaceutical and non-pharmaceutical treatments. The integrity and credibility of CME provided by medical associations has been questioned because it has become so closely linked with the marketing initiatives of the pharmaceutical industry [3, 6–8]. Data from the United States (US) suggests that, in 2014, support from the pharmaceutical industry accounted for approximately 25% of total income reported by CME providers [9]. Although industry representatives maintain that the intent behind their funding of CME is motivated by the desire to provide up-to-date information to doctors, researchers independent from the pharmaceutical industry suggest that this financial support is used to advance sponsors’ marketing interests [3, 10, 11]. Funding for CME is generally considered by researchers to be part of the marketing budget, dedicated to producing sales, and they include it when reporting promotional expenses [12, 13]. Fugh-Berman and Hogenmiller argue that even when CME activities have not received pharmaceutical industry funding, speakers who are funded by industry can still be used [14].

Tools have been developed for evaluating the potential for bias within CME presentations but they do not evaluate the policies that medical associations have adopted to guide industry involvement prior to the CME event [15–17]. The purpose of this study is twofold: we present an original tool for evaluating policies adopted by PMAs concerning financial conflict of interest (FCOI) relationships and industry involvement in CME. We, then, use the tool to conduct a systematic evaluation of CME policies that have been adopted by Canadian PMAs.

2 Methods

3 Results

We assessed 236 policies, which were collectively adopted by 60 Canadian PMAs (range, 0 to 32 policies per association) and the coalition. Eight documents were inaccessible (“page not found” or “link broken”: 7 documents, password login required to view policy: 1 document) (Appendix 2).

The dates of 112 documents were not provided. The remaining 124 policies ranged in date from 2004 to 2016. Although the joint policy from the coalition will not come into effect until 2018 it was drafted in 2016. One document was more than 10 years old, while 69 were adopted within four years of March 2016 (Appendix 2).

The Canadian Medical Association’s policy on physicians’ interactions with industry [22] was formally adopted by 22 out of 60 Canadian medical associations, while 30 associations plus the coalition reference it in their own policies. For the RCPSC guidelines, the corresponding numbers are 15 and 20, respectively.

Twenty-seven associations received an overall score of 0/63 (0%), indicating that these associations either had no publicly available policies or that their policies did not address the items in the scoring tool. The remaining 34 medical associations received scores that ranged from 9/63 (14.3%) to 31/63 (49.2%) (median: 23.0 (37.7%), interquartile range [IQR]: 21 to 24.0 (34.4% to 39.3%)). The joint policy from the coalition was the only policy to receive a score of 3 for any item (satellite symposia), which represents the greatest restrictiveness (Appendix 3).

The highest mean scores (1.1/3) were achieved in the areas of pharmaceutical industry involvement in planning CME activities, presence of a review process for topics of CME activities, content review for balanced information, and responsibility of distribution of funds (mean: 1.0/3). The lowest mean scores were achieved in the areas of awards (0.0/3), industry personnel, representatives, and employees, distribution of industry-funded educational materials at CME activities, and distinction between marketing and educational materials (0.1/3) (Appendix 3; Table 1). None of the 21 items were addressed by all policies. Awards was not addressed by any association, while the most frequently addressed item was presence of a review process for topics of CME activities (34 of 60 associations plus the coalition) (Table 1).

Twenty-three (38%) PMAs publicly disclosed that they accepted industry sponsorship (Q1), while 49 (82%) PMAs received industry sponsorship specifically for CME activities (Q2). The policies adopted by 34 of the 60 medical associations plus the policy from the coalition identified a party responsible for oversight to ensure compliance (EA) (Table 2), e.g., the “planning committee” or “chair of the planning committee” [23]. Eighteen of the 60 medical associations plus the coalition identified sanctions for noncompliance with the policies, e.g., an RCPSC COI disclosure form stated that “Failure to disclose or false disclosure may require the Planning Committee to replace the speaker” [23]. The College of Family Physicians of Canada adopted the most extensive description of action in cases of CFPC policy violation [24]. None of the medical associations stated within their policies that the results of the investigations into noncompliance would be made accessible on the society’s website.

The 60 Canadian professional medical associations plus the coalition received scores that ranged from 0% to 49.2% of the maximum possible score. Approximately half of the medical associations received scores of 16/63 (25.4%) or lower. The remaining 30 medical associations received scores between 17/63 (27.0%) and 31/63 (49.2%). Out of the 124 policies where dates were provided, 69 were developed within the previous 4 years. Therefore, in these cases we do not feel that the poor scores reflect older policies that may have been adopted before FCOI became a concern.

In general, the items that had the highest mean scores received scores of 2/3 indicating that the medical associations retained complete control over the planning and topics of CME activities and were responsible for ensuring the validity and objectivity of educational material. The item concerning responsibility for distribution of funds usually received a score of 2/3 indicating that PMAs’ CME committees held the responsibility for distributing grants from industry. The RCPSC has stated that companies that provide educational grants possess “ ... legal obligations to ensure any financial support provided is directed to a specific event or activity” [25].

The lowest scores were received in the areas of awards (mean: 0.0/3), industry personnel, representatives, and employees, distribution of industry-funded educational materials at CME activities, and distinction between marketing and educational materials (mean: 0.1/3). Only 13 out of 60 medical associations plus the coalition addressed the item regarding funding for CME activities in their policies, mean score of 0.3/3, indicating that medical associations tend to permit one or more pharmaceutical industry sponsors to provide funding for CME events.

Scores of 1/3 indicate permissiveness and tend to have an effect which is equal to that of a non-existent policy. However, it was important to distinguish between areas where even permissive policies existed and where policies were non-existent. This distinction allows CME participants and providers to identify the areas that have been addressed, even if permissively, as opposed to completely left out.

Given the number of medical associations that formally include or reference the guidelines from either the Canadian Medical Association or the Royal College of Physicians and Surgeons of Canada, if one or both of these associations changed their guidelines, those changes would have a wide ranging effect. A similar effect might be seen depending on how the medical associations deal with the new policy from the coalition once that policy becomes effective in 2018.

Critics of conflict of interest regulation might argue that adopting and enforcing stringent policies assumes wrongdoing and attaches blame to the individual or institution engaging in the financial relationship [26]. However, and importantly, this criticism may not appreciate the degree to which institutional FCOI relationships could threaten not only the trust that physicians and patients have in the roles of associations [26], but also the independence of the content included within CME programs [27].

International literature on institutional financial relationships between PMAs and the pharmaceutical industry supports the need for critical analysis of their policies on industry involvement and influence in CME activities. Cosgrove and Bursztajn argue that if CME activities are sponsored by industry, the completeness and accuracy of the educational information provided may be not only incomplete, but also biased [28]. They recommend a system of checks and balances and clear enforceable policies to safeguard against the potential for industry influence in the CME activities in which physicians participate.

Not all off-label mentions in CME events are necessarily inappropriate or commercially driven, but off-label prescribing is encouraged through teaching and research activities, including CME [29]. In over half of the cases in the study by Kesselheim and colleagues, speakers chosen for CME were known to promote off-label medication use. Steinman and colleagues found that drug companies use CME activities as a venue for direct-to-physician promotion to convince both current prescribers and non-prescribers to increase new prescriptions [30]. Off-label prescribing can be appropriate, but in most cases there is little scientific evidence to justify it [31].

It is possible for PMAs to reduce their financial dependence on, and relationships with, industry. At its annual meeting and CME conferences, the North American Spine Society prohibits company logos on promotional items and does not sell lists of CME participants to companies in order to prevent “robo calls” to participants’ hotel rooms at CME events. It further rejects funding for meals and snacks at its CME events. To account for the decrease in industry funding for CME, annual membership and meeting registration fees and fees charged for exhibit hall booths were increased modestly, although some commentators do not view this as an acceptable alternative [10]. Despite these modest increases, physician membership has also increased [32]. The Oregon Academy of Family Physicians no longer accepts any grants, restricted or unrestricted, for its CME events or allows drug companies to have booths in its exhibit hall during conferences [33]. In response to the increasing awareness and concern over industry’s influence via financial relationships, over 100 large medical institutions in the US severed their financial ties with industry [34].

In Canada, CME programs for physicians receive a substantial portion of funding from pharmaceutical and medical device companies, although it is widely accepted that industry involvement in education influences physicians’ prescribing choices [8, 35]. It is unlikely that companies would donate substantial funds without any expectation of return from increased sales [8].

5 Limitations

Although we attempted to make the scoring tool as universally applicable as possible, some associations’ policies and documents included important areas for which the scoring tool did not account, for example peer selling and FCOI of CME moderators or facilitators. We view our tool as a living document that needs further study and refinement and in this process these additional items and other areas should be addressed.

We attempted to do a thorough search of each association but it is possible that the key words that we used and our manual searches missed relevant policies.

Where policies did not directly reflect the content of the scoring system, we had to determine if their contents complied with the spirit of the scoring system and, therefore, our interpretation of the policy may have had a subjective element. Importantly, the overall score for each policy for a single item may have been based on more than one phrase in one or more policies of a PMA. Although the scoring tool separated FCOI into many discrete activities, associations’ policies were not necessarily structured in the same way. Therefore, a clause in a policy could have been relevant to more than one item in the tool and, as a result, would have been scored under both items.

We did not contact medical associations to see if they were in agreement with our assessments. We also evaluated policies without analyzing any CME events sponsored by these associations. Despite permissive policies, CME events accredited by PMAs might still be free of possible industry bias. A comparison of policies and practice is an area for future research in order to determine the extent to which policies are implemented and enforced.

Finally, although we attempted to ensure that our tool had face validity by having it peer reviewed we recognize that there will always be an element of subjectivity in any such tool.

6 Conclusion

We conducted a comprehensive evaluation of the policies on CME activities and industry involvement adopted by 60 Canadian medical associations plus the new policy from the coalition. We found the publicly available policies to be generally weak or non-existent. This weakness was coupled with the majority of associations having disclosed industry sponsorship for CME activities in the last five years. The next step is to evaluate whether the policies in place lead to a bias in the topics and content of CME and if these biases exist whether they are due to weaknesses in the policies.

Should there be an association between deficiencies in the policies and biases then in order to avoid institutional FCOI relationships with industry, PMAs should avoid seeking and accepting industry funding for CME activities. Alternative mechanisms for financing CME activities may include modestly increasing membership dues and registration costs [36]. Another approach might include lobbying provinces to reimburse physicians for attending CME events and some provinces have already taken this initiative [37]. PMAs could also lessen possible bias by only accepting anonymous industry sponsorship, a move recommended by a recent report from the College of Family Physicians [38].

The Canadian PMAs ought to take a leadership position on behalf of their physician members and the patients that they serve when it comes to acceptable conduct in the context of FCOI relationships [36]. We urge the medical associations that have not adopted any policies to, at the very least, adopt the policies from the Royal College of Physicians and Surgeons of Canada and the Canadian Medical Association or the new policy from the coalition. We also encourage Canadian PMAs to review and strengthen their policies to protect the integrity of the education that Canadian physicians are receiving and applying in the treatment of their patients.

Conflict of interest

The authors have no conflict of interest to report.